Data / Medical devices / Japan / FUJI SYSTEMS CORPORATION, Shin-Shirakawa Plant

FUJI SYSTEMS CORPORATION, Shin-Shirakawa Plant: FDA-registered device maker in Shirakawa Fukushima, Japan, 6 510(k) clearances

Name: FUJI SYSTEMS CORPORATION, Shin-Shirakawa Plant FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

FUJI SYSTEMS CORPORATION, Shin-Shirakawa Plant is registered with the FDA (registration 3014766734) in Shirakawa Fukushima, Japan. It lists 8 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 9, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3014766734
Address: 1-23 Tsukinoiri, Kayane, Shirakawa Fukushima, Japan, 961-0004
Owner or operator: FUJI SYSTEMS CORPORATION (9052600)
Roles: Contract manufacturer, Manufacturer
First device listed: November 1, 2007
Registered through: 2026
Brand names listed: CELLO Balloon Guide Catheter; 6F, 7F, 8F, 9F, Pediatric Cuffed And Uncuffed Et Tube; Standard Cuffed and Uncuffed Et Tube, Phycon All Silicone Balloon Catheter, Silbroncho Double Lumen Tube, Univent Tube 7mm, 7.5mm, 8mm, 8.5mm, 9mm, Wire Reinforced Endotracheal Tube

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Percutaneous	DQY	2	Manufacturer	accessdata.fda.gov
Catheter, Percutaneous, Neurovasculature	QJP	2	Manufacturer	accessdata.fda.gov
Catheter, Retention Type, Balloon	EZL	2	Manufacturer	accessdata.fda.gov
Endoscope, Accessories, Narrow Band Spectrum	NWB	2	Contract manufacturer	accessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-Urology	FED	2	Contract manufacturer	accessdata.fda.gov
Enteroscope And Accessories	FDA	2	Contract manufacturer	accessdata.fda.gov
Tube, Tracheal (W/Wo Connector)	BTR	2	Manufacturer	accessdata.fda.gov
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	CBI	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 9, 2022	K223275	CELLO II Balloon Guide Catheter	QJP	Substantially Equivalent	Fuji Systems Corporation	accessdata.fda.gov
August 9, 2012	K120781	CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH	DQY	Substantially Equivalent	Fuji Systems Corp.	accessdata.fda.gov
August 17, 2005	K051522	SILBRONCHO DOUBLE LUMEN TUBE	CBI	Substantially Equivalent	Fuji Systems Corp.	accessdata.fda.gov
November 2, 1993	K932647	WIRE REINFORCED ENDOTRACHEAL TUBE	BTR	Substantially Equivalent	Vitaid, Ltd.	accessdata.fda.gov
April 25, 1990	K894883	PHYCON ALL SILICONE BALLOON CATHETER	EZL	Substantially Equivalent	Vitaid, Ltd.	accessdata.fda.gov
September 29, 1989	K894337	UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM	CBI	Substantially Equivalent	Vitaid, Ltd.	accessdata.fda.gov

Compare with other makers

Updated December 9, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.